Sinu Co., Ltd

CLOSEOUT LETTER Sinu Co., Ltd MARCS-CMS 585410 — October 21, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Dong Min Lee Recipient Title President Sinu Co., Ltd B-501, 1 Wonyang-ro Seo-gu Busan 49277 South Korea Issuing Office: Center for Food Safety and Applied Nutrition 5001 Campus Drive College Park , MD 20740 United States Dear Mr. Lee: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 585410, issued July 24, 2019. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Robyn R. Jones Team Leader Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 10/24/2019 Regulated Product(s) Food & Beverages